MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS

Catalog Number 8603800

Device Problems Device Operates Differently Than Expected (2913); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the ventilator failed during procedure.The patient needed to be ventilated with bag.There was no injury reported.

Manufacturer Narrative

The investigation was carried out based on the available information and submitted electronic device logfile.Though requested, the hardware was not returned for an investigation.Based on the available logfiles, the reported symptom of ventilator failure could be understood.Entries were found in the logfile that the battery was totally discharged and entries indicating that the battery was old.The anesthesia device behaved as specified and alerted the condition accordingly.The batteries are subject to an aging process and are replaced periodically during product maintenance (each 3 years).Therefore, a possible root cause for the reported symptom is a mains or power supply failure leading to a ventilator failure because of power loss.Since the material was not returned for investigation, this could not be verified.In case of a ventilator failure during automatic ventilation, the ventilator initiates an autonomous shutdown while changing mode to man/spont (safety mode) and generating the appropriate ventilator fail alarm.Manual ventilation in man/spont-mode and switched off-state remains possible.In case of power failure and empty batteries, manual ventilation with 100% o2 with a flow of up to 12 l/min is still possible by using the safety knob for o2 emergency delivery as described in the ifu.As the o2 flows through the vaporizer, dosage of anesthetic agent remains possible as well.

Event Description

Please refer to the initial-report.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck, 23542 ; GM 23542
• MDR Report Key: 7494130
• MDR Text Key: 107719694
• Report Number: 9611500-2018-00133
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1